CurrentUnitedHealthcarePolicy N/A

Transmucosal and compounded fentanyl prior authorization

Prior authorization and notification requirements for Actiq, Fentora, generic fentanyl citrate lozenges, and compounded fentanyl preparations for management of breakthrough cancer pain in opioid-tolerant patients.

Policy Summary

PayerUnitedHealthcare

PolicyTransmucosal and compounded fentanyl prior authorization

Policy CodePolicy N/A

Change TypeNo material change

Effective DateAug 1, 2025

Next Review DateN/A

Key ActionSubmit medical records documenting breakthrough cancer pain and opioid tolerance meeting specified dose thresholds to request prior authorization.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

12 monthsauthorization duration

>=60 mg/dayoral morphine threshold

25 mcg/hrtransdermal fentanyl threshold

Single producttransmucosal product rule

8/1/2025policy effective date

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Coverage Criteria

Actiq, Fentora, generic fentanyl citrate lozenges - Initial Coverage

Covered when ALL of the following are met:

Primary indication: Use is for the management of breakthrough pain associated with a cancer diagnosis (cancer diagnosis must be documented in the medical records).

Opioid tolerance: Patient must have at least a one week history of one of the specified opioid regimens meeting listed dose thresholds (e.g., oral morphine ≥ 60 mg/day; fentanyl transdermal ≥ 25 mcg/hr; oral oxycodone ≥ 30 mg/day; oral hydromorphone ≥ 8 mg/day; oral oxymorphone ≥ 25 mg/day; oral hydrocodone ≥ 60 mg/day; or an equianalgesic opioid dose such as oral methadone ≥ 20 mg/day).see thresholds

Around-the-clock therapy: Patient is currently taking a long-acting opioid around the clock for cancer pain.

Transmucosal product status: Either the patient is not concurrently receiving an alternative transmucosal fentanyl product OR the prescriber requests termination of all current authorizations for alternative transmucosal transmucosal fentanyl products to begin the requested medication (only one transmucosal fentanyl product will be approved at a time). If previous authorizations cannot be terminated, the PA request will be denied.

Compounded fentanyl - Initial Coverage

Covered when ALL of the following are met:

Primary indication: Use is for the management of breakthrough pain associated with a cancer diagnosis (cancer diagnosis must be documented in the medical record).

Opioid tolerance: Patient must have at least a one week history of one of the specified opioid regimens meeting listed dose thresholds (see thresholds).see thresholds

Around-the-clock therapy: Patient is currently taking a long-acting opioid around the clock for cancer pain.

Unique dosage form need: A unique dosage form is required for a product that is not commercially available due to the patient's age or weight.

Transition/One-time Fill

Transition supply: Patients currently taking the listed fentanyl products who do not meet notification criteria based on the FDA-approved indication for breakthrough cancer pain may be approved for a one-time fill for transition to an alternative treatment.

Coverage of specific transmucosal fentanyl products varies by plan. Actiq (brand only), fentanyl bulk powder, and Fentora are typically excluded from coverage; plan-specific tried/failed criteria or other restrictions may apply. Refer to the member’s benefit plan and any applicable state or federal mandates for definitive coverage determinations.

Use of transmucosal fentanyl products in patients who are not opioid tolerant is contraindicated. These products must not be used in opioid non‑tolerant patients because life‑threatening hypoventilation could occur at any dose in patients not maintained on a chronic opioid regimen.

Initial Therapy - Transmucosal Fentanyl

Initial Therapy - Transmucosal fentanyl

Initial use criteria for transmucosal fentanyl products:

Initial therapy criteria: Medical records document breakthrough cancer pain with a cancer diagnosis; patient has opioid tolerance demonstrated by at least one week of an opioid regimen meeting dose thresholds; patient is on long-acting around-the-clock opioid therapy; and only one transmucosal fentanyl product will be active at a time.see thresholds

Re-authorization / Continuation Criteria

Re-authorization

Re-authorization considerations:

Re-authorization: Authorization will be approved for 12 months; re-authorization requires documentation that original coverage criteria continue to be met and may be automated based on claim history/diagnosis codes per program.12 months

Provider Actions and Documentation

Prior Authorization

Transmucosal fentanyl PA requirement

Prior authorization is required for transmucosal fentanyl products (e.g., Actiq, fentanyl citrate lozenges, Fentora). Approvals are granted when medical records document that use is for management of breakthrough pain associated with a cancer diagnosis and the patient meets opioid tolerance criteria and other requirements below.

Submit medical records confirming a cancer diagnosis and that the medication is for breakthrough cancer pain.
Document opioid tolerance: at least 1 week history of one of the following doses — oral morphine ≥ 60 mg/day; fentanyl transdermal ≥ 25 mcg/hr; oral oxycodone ≥ 30 mg/day; oral hydromorphone ≥ 8 mg/day; oral oxymorphone ≥ 25 mg/day; oral hydrocodone ≥ 60 mg/day; or an equianalgesic dose (e.g., oral methadone ≥ 20 mg/day).
Patient must be taking a long-acting (around-the-clock) opioid for cancer pain.
Only one transmucosal fentanyl product will be approved at a time. If patient is currently receiving another transmucosal fentanyl product, the prescriber must request termination of all current authorizations for the alternative product(s); if prior authorizations cannot be terminated, the PA request will be denied.
Authorization, when approved, will be for 12 months.

Prior Authorization

Compounded fentanyl PA requirement

Prior authorization is required for compounded fentanyl formulations. Approvals are granted when medical records document breakthrough cancer pain, opioid tolerance as defined below, need for a unique dosage form, and other requirements below.

Submit medical records confirming a cancer diagnosis and that the compounded product is for breakthrough cancer pain.
Document opioid tolerance: at least 1 week history of one of the following doses — oral morphine ≥ 60 mg/day; fentanyl transdermal ≥ 25 mcg/hr; oral oxycodone ≥ 30 mg/day; oral hydromorphone ≥ 8 mg/day; oral oxymorphone ≥ 25 mg/day; oral hydrocodone ≥ 60 mg/day; or an equianalgesic dose (e.g., oral methadone ≥ 20 mg/day).
Patient must be taking a long-acting (around-the-clock) opioid for cancer pain.
A unique dosage form that is not commercially available due to the patient's age or weight must be documented to justify compounded fentanyl.
Only one transmucosal fentanyl product will be approved at a time. If patient is currently receiving another transmucosal fentanyl product, the prescriber must request termination of all current authorizations for the alternative product(s); if prior authorizations cannot be terminated, the PA request will be denied.
Authorization, when approved, will be for 12 months.

Documentation Required

Medical records and diagnosis documentation

Submit complete medical records and documentation with the PA request to demonstrate the covered indication and opioid tolerance. Records should clearly show the cancer diagnosis, the clinical rationale for transmucosal or compounded fentanyl, the specific opioid doses and duration used to establish tolerance, current long-acting opioid therapy, and any request to terminate prior transmucosal fentanyl authorizations if applicable.

Medical records must document cancer diagnosis and that the fentanyl product is for breakthrough cancer pain.
Include medication history showing at least one week at the opioid doses listed under tolerance criteria.
If switching from another transmucosal fentanyl product, include prescriber request to terminate existing authorizations (only one transmucosal fentanyl product will be approved at a time).
Plan-specific coverage limits, exclusions (e.g., Actiq brand only, fentanyl bulk powder, Fentora), and state/federal mandates may apply — verify member-specific plan details.

Coding and Dose Thresholds

Opioid tolerance dose thresholds — inv-06: key thresholds

Oral morphine≥60 mg/day

Transdermal fentanyl≥25 mcg/hr

Oral oxycodone≥30 mg/day

Oral hydromorphone≥8 mg/day

Oral oxymorphone≥25 mg/day

Oral hydrocodone≥60 mg/day

Equianalgesic alternative (example)Oral methadone ≥20 mg/day

Definitions

Opioid tolerant — inv-13: definition and thresholds

DefinitionOpioid tolerant: taking specified opioid doses for a week or longer (see thresholds).

Minimum durationAt least one week of the listed opioid regimen

Required contextPatient must be on around-the-clock long-acting opioid therapy while using transmucosal fentanyl

Numeric thresholds (summary)Oral morphine ≥60 mg/day; transdermal fentanyl ≥25 mcg/hr; oral oxycodone ≥30 mg/day; oral hydromorphone ≥8 mg/day; oral oxymorphone ≥25 mg/day; oral hydrocodone ≥60 mg/day; or equianalgesic opioid dose (e.g., methadone ≥20 mg/day)

Background

Actiq, Fentora, and fentanyl citrate lozenges are indicated for the management of breakthrough cancer pain in patients who are already receiving and have developed tolerance to around‑the‑clock opioid therapy. Opioid tolerance is defined as at least one week of therapy at one of the specified dose thresholds (for example, oral morphine ≥60 mg/day or transdermal fentanyl ≥25 mcg/hour), and patients must remain on around‑the‑clock opioids while using these transmucosal fentanyl products. Compounded fentanyl preparations may be considered only when a unique dosage form is required for an individual patient and a commercially available product is not appropriate; compounded preparations should be made for a single individual and not produced on a large scale.

Step Therapy

Step	Requirement/Note
1	Refer to plan specifics — tried/failed criteria, exclusions (e.g., Actiq brand, fentanyl bulk powder, Fentora), and any supply limits or other utilization management programs may apply. Authorization duration typically 12 months; state mandates and member benefit plans may affect coverage.
2	Prior authorization and medical necessity determination may be required per plan; consult plan-specific documentation for exact requirements.

Quantity Limits

Transmucosal fentanyl products — inv-17: plan-specific supply limits

Supply limitsSupply limits may be in place per plan (plan-specific quantity limits).

Prior authorizationPrior authorization/medical necessity programs may apply to transmucosal fentanyl products.

Compound/bulk notificationsCompound and bulk powder notification requirements may apply.